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勤務地: Tokyo, Kanto
給与: ご相談可能
言語: Japanese > Native, English > Business Level
Sub-industry: Pharmaceuticals
職種: ヘルスケア/研究開発

会社概要

A global pharmaceutical company

仕事内容

Ensure the timely collection, assessment, coding and processing of serious adverse event reports related to the clinical or marketed drug products within the established time frames and in compliance with global regulatory requirements. In this role, the individual will serve as primary oversight for receipt and accurate entry of serious adverse events into the Safety Database.
1. Manage local PV activities, such as adverse event monitoring, safety reporting, risk management, local safety monitoring activities as required by local agency, local contractual agreements, process documentation and training, inspection preparedness, and any other required country-specific safety activity
2. Manage case processing activities, and review processed cases to verify accuracy, consistency and compliance with process requirements
3. Participate in compliance activities

応募資格

• Bachelor’s degree in science or health care related field.
• Ideally, at least 7 years’ experience in the pharmaceutical industry with at least 5 years in a drug safety/pharmacovigilance role.
• Experience working with drug safety databases and managing and tracking of
serious adverse event reports

その他情報

JO-200827-224864

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